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NICE recommends Pharmalgen for bee and wasp allergy in final draft guidance

In final draft guidance issued today (Friday 16 December), NICE, the healthcare guidance body, has recommended Pharmalgen (made by ALK-Abelló) as a treatment option for IgE-mediatedi bee and wasp venomii allergy in people who have had:

  • a severe systemic reaction to bee or wasp venom, or
  • a moderate systemic reaction to bee or wasp venom and who have one or more of the following: raised baseline serum tryptaseiii, a high risk of future stings, or are anxious about future stings.

Treatment with Pharmalgen should be initiated and monitored in a specialist centre experienced in venom immunotherapy.

Bee and wasp venom contains chemicals that produce an intense, burning pain followed by redness and swelling when a person is stung. This usually eases within a few hours, but less than 0.5% of the population who are stung by a bee or wasp experience a severe allergic reaction known as anaphylaxisiv. It is estimated that of all deaths from anaphylaxis between 1992 and 2001 in the UK, approximately 62%, were a result of reactions to wasp venom and approximately 9% were caused by reactions to bee venom. Less common allergic reactions are conjunctivitis, rhinitis and gastrointestinal reactions. Bee venom allergy occurs largely in those who are exposed to bees and are frequently stung, such as beekeepers, their relatives or neighbours. Wasp venom allergy is much more common in the UK, occurring as a result of random occasional stings.v.

Pharmalgen works as a preventative treatment in those people who experience allergic reactions to bee or wasp stings. The treatment works by administering gradually increasing doses of the allergen by injection, which over time desensitises a person with an allergy by altering their immune system. Treatment is carried out in two phases: the initial phase and the maintenance phase, which lasts three years.

This is not NICE's final guidance and the recommendations may change in the event of an appeal.

Professor Peter Littlejohns, Clinical and Public Health Director at NICE said: “NICE is pleased to recommend Pharmalgen as a clinically and cost effective preventative treatment for bee and wasp allergy in final draft guidance issued today. Reactions from such stings can be upsetting, frightening and sometimes life-threatening. People who have had a serious reaction to a sting can often experience extreme anxiety about possible future stings, and this can affect their day to day lives. I am sure this decision will be welcome news to all those affected by this often distressing allergy.”

The final draft guidance will be available on the NICE website from Friday 16 December.

NICE has not yet issued final guidance to the NHS; registered stakeholders now have the opportunity to appeal against these draft recommendations and consequently they may change in the event of an appeal being received.

Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its guidance on a technology it replaces local recommendations across the country.

Final guidance is expected to be published in February 2012.

Ends

Notes to Editors

About the guidance

1. The final draft guidance is available from Friday 16 December on the NICE website at http://guidance.nice.org.uk/TA/Wave23/28

2. Pharmalgen (ALK-Abelló) Bee Venom Extract has a UK marketing authorisation for the diagnosis and treatment of IgE-mediated allergy to bee venom. Pharmalgen Wasp Venom Extract has a UK marketing authorisation for the diagnosis and treatment of IgE-mediated allergy to wasp venom.

3. NICE will not be looking at the use of Pharmalgen in the diagnosis of allergy to bee and wasp venom.

4. Treatment with Pharmalgen is in two phases: an initial phase and a maintenance phase. Before people receive Pharmalgen, IgE-mediated allergy to bee or wasp venom must be confirmed by case history and by in vivo and/or in vitro diagnosis. Pharmalgen must be given by subcutaneous injection.

5. During the initial phase, patients receive an increasing dose of Pharmalgen until the maximum tolerated dose is reached. During this phase, patients may undergo a conventional dosing schedule (one injection every 3-7 days), a clustered dosing schedule (2-4 injections per week at intervals of 30 minutes) or a rush dosing schedule (one injection every 2 hours with a maximum of 4 injections per day). During the maintenance phase, a concentration of 100 micrograms/ml of Pharmalgen is administered every 4 -6 weeks for a period of at least 3 years. The dosage of Pharmalgen may be adjusted depending on the person's history of allergic reactions and sensitivity to the specific allergen used.

6. Pharmalgen Bee Venom Extract costs £54.81 for an initial treatment set and £63.76 for a maintenance treatment set (excluding VAT; ‘British national formulary' [BNF] edition 61).The maintenance treatment set includes 4 vials. Therefore, the cost per injection in the maintenance phase is £15.94. Pharmalgen Wasp Venom Extract costs £67.20 for an initial treatment set and £82.03 for a maintenance treatment set (excluding VAT; ‘British national formulary' [BNF] edition 61). The maintenance treatment set also includes 4 vials; therefore, the cost per injection in the maintenance phase is £20.51. Costs may vary in different settings because of negotiated procurement discounts.

References

i. IgE (immunoglobulin)-mediated reactions are acute and frequently have a rapid onset.

ii. Venom is the poisonous secretion of an insect or animal usually transmitted by a bite or sting.

iii. Tryptase is an enzyme of human mast cells that has been implicated as a pathological mediator of various allergic and inflammatory conditions.

iv. Anaphylactic, generalised type I reactions (that is, immediate hypersensitivity reactions) involve immunoglobulin E (IgE)-mediated release of histamine. Anaphylaxis can be severe and potentially fatal. Anaphylactic reactions are of variable presentation and typically come on quickly (within 15 minutes from the sting), although they may occur up to one hour after the sting. Initial symptoms are usually cutaneous (in the skin) followed by hypotension (low blood pressure), with light-headedness, fainting or collapse. Some people develop respiratory symptoms due to either asthma or laryngeal oedema (allergic swelling of the throat). However, a few people have little or no warning before collapsing and losing consciousness.

v. The final scope for the appraisal of Pharmalgen for the treatment of allergy venom.

About NICE

1. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.

2. NICE produces guidance in three areas of health:

  • public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
  • health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
  • clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

3. NICE produces standards for patient care:

  • quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
  • Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients.

4. NICE provides advice and support on putting NICE guidance and standards into practice throughits implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.

This page was last updated: 14 December 2011

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Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.